Evaluation of Pulpotomy Versus Pulpectomy in Primary Molars With Irreversible Pulpitis or Necrotic Pulp

NCT07230717 | Not Yet Recruiting

• 1 other identifier: D-S-H-22-Jun
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Preserving primary teeth until their normal exfoliation time is crucial for maintaining the child's normal function, esthetics, arch integrity, and correct eruption of permanent successors. Given the growing interest in conservative procedures and the clinical need for simpler, more predictable pulp therapy outcomes in children, evaluating pulpotomy with Pulpotec as a potential alternative to pulpectomy is essential. The aim of this study is to evaluate the clinical and radiographic success of pulpotomy using Pulpotec versus pulpectomy using Metapex, a calcium hydroxide with iodoform paste, to treat primary molars in children diagnosed with irreversible pulpitis or necrotic pulp in the Postgraduate Pediatric Dental Clinic at Ajman University, UAE. A total of 25 contralateral paired molar samples from children aged 4 to 8 will be included in this split-mouth randomized controlled study. Each child will serve as their own control, with one tooth randomized to the intervention group (Pulpotomy using Pulpotec) and the other to the control group (Pulpectomy using Metapex) to assess patients' clinical and radiographic outcomes over a 12-month follow-up period. Patients will have their dental anxiety psychometrically assessed using the RMS pictorial scale. In addition, a pulse oximeter will be used as a biological marker in the study to measure oxygen saturation and pulse rate.

Conditions

Pulp Therapy; Pulpitis - Irreversible; Pulp Necrosis

Keywords

Pulpotomy; Pulpectomy; primary molars; irreversible pulpitis; necrotic pulp

Outcome Measures

Primary Outcomes (1)

• Clinical and radiographic success rates of pulpotomy versus pulpectomy in primary molars of children with irreversible pulpitis or necrotic pulp over a 12-month follow-up period

  The outcome will assess and compare the clinical and radiographic success rates of pulpotomy and pulpectomy procedures performed in primary molars diagnosed with irreversible pulpitis or necrotic pulp. Clinical success will be defined by the absence of pain, swelling, sinus tract, mobility, or tenderness to percussion. Radiographic success will be defined by the absence of periapical or inter-radicular radiolucency, internal or external resorption, and evidence of continued root resorption consistent with normal exfoliation.

  3 months, 6 months, 9 months, and 12 months follow up post-treatment.

Secondary Outcomes (3)

• Anxiety Level using RMS Pictorial Scale

  Baseline (in the waiting area before entering the operatory), Pre-operative (immediately before the start of the procedure), Operative (during the dental treatment), and Post-operative (immediately after completion of the procedure).

• Pulse Rate in beats per minute (bpm) using Pulse Oximeter

  Baseline (in the waiting area before entering the operatory), Pre-operative (immediately before the start of the procedure), Operative (during the dental treatment), and Post-operative (immediately after completion of the procedure).

• Oxygen Saturation (SpO₂) in percentage (%) using Pulse Oximeter

  Baseline (in the waiting area before entering the operatory), Pre-operative (immediately before the start of the procedure), Operative (during the dental treatment), and Post-operative (immediately after completion of the procedure).

Study Arms (2)

Pulpotomy

EXPERIMENTAL

Pulpotomy

Procedure: Pulpotomy

Pulpectomy

ACTIVE COMPARATOR

Pulpectomy

Procedure: Pulpectomy

Interventions

Pulpotomy PROCEDURE

Pulpotomy with pulpotec Powder: (iodoform, polyoxymethylene, excipient) and a Liquid: (dexamethasone acetate, formaldehyde, phenol, guaiacol, excipient) mixed into a paste consistency as per manufacturer instruction. Pulpectomy with metapex Content: Calcium Hydroxide, Iodoform, Silicon oil

Pulpotomy

Pulpectomy PROCEDURE

Calcium Hydroxide, Iodoform, Silicon oil

Pulpectomy

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients in healthy medical conditions
• Bilateral/contralateral primary molars diagnosed with irreversible pulpitis or necrotic pulp
• Periapical or bifurcation radiolucency
• Chronic apical intraoral abscess
• Sinus tract or fistula formation
• No tooth mobility or grade I mobility
• External root resorption less than or equal to 1/3rd of the roots
• Tooth should be restorable

You may not qualify if:

• Patients who are medically compromised (with systemic conditions)
• Acute extraoral abscess
• Grade II or III tooth mobility
• External root resorption in more than 1/3 of roots
• Physiological root resorption of more than 1/3 of the roots or near exfoliation
• Non-restorable teeth

Sponsors & Collaborators

• Ajman University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Pulpotomy; Pulpectomy

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: November 17, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11